Open-Label Extension of EryDex Study IEDAT-04-2022 (OLE_NEAT)

Quince Therapeutics S.p.A.

Status and phase

Enrolling

Phase 3

Conditions

Ataxia Telangiectasia

Treatments

Drug: Dexamethasone sodium phosphate

Study type

Interventional

Funder types

Industry

Identifiers

NCT06664853

IEDAT-05-2024

Details and patient eligibility

About

This is an international, multi-center, prospective, open-label, non-comparative study to provide EryDex treatment to ataxia telangiectasia (A-T) patients who complete the IEDAT-04-2022 trial on the neurological effects of EryDex on subjects with ataxia telangiectasia (NEAT trial).

Full description

The IEDAT-05-2024 study aims to provide EryDex (dexamethasone sodium phosphate encapsulated into autologous erythrocytes) treatment to patients who complete the full study treatment period (including those receiving placebo) in the IEDAT-04-2022 (NEAT) study, who complete the study assessments, do not present safety contraindications to continuation of treatment, and provide informed consent. The open-label extension (OLE) treatment period will be 12 months. Participants will be considered to have completed the study when Visit 14 (Safety Follow-up) has been performed.

Enrollment

106 estimated patients

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

body weight ≥15 kg
participation in IEDAT-04-2022 study and its completion, including final efficacy and safety assessments

Exclusion criteria

safety contraindications for continuation of treatment, as determined by the investigator
clinically significant immune impairment that, in the opinion of the Investigator, precludes further treatment with corticosteroids
Current neoplastic disease or previous neoplastic disease not in remission for at least 2 years.
requiring treatment with a systemic corticosteroid